Senior Clinical Trial Manager – Non‑Interventional Studies

About the role

The Senior Clinical Trial Manager leads non‑interventional studies, ensuring the final clinical deliverable—clean, evaluable patient data—is achieved on time, within budget, and to the required quality standards. The role operates independently on moderate to high‑complexity projects and may assume regional lead or Clinical Study Manager responsibilities.

Key responsibilities

• Manage all clinical operational and quality aspects of assigned studies in compliance with ICH GCP.
• Develop and maintain clinical tools such as Monitoring Plans, Monitoring Guidelines, and Data Quality Plans.
• Contribute to the Master Action Plan and ensure proper setup and maintenance of the Trial Master File (local and central).
• Participate in the design of CRFs, informed consent templates, and other protocol‑specific documents.
• Collaborate with project managers to prepare client presentations, bid defenses, and hand‑off meetings.
• Lead team communications, monitor timelines, and implement recovery actions to meet contractual deadlines.
• Implement and train standardized clinical monitoring processes and oversee document archiving.

Required profile

• Proven ability to deliver final clinical data within contractual timeframes.
• Experience interpreting complex data and making business decisions with line‑management support.
• Track record of independent work on moderate to high‑complexity clinical projects.
• Capability to assume regional lead or Clinical Study Manager duties as needed.

Required skills

• ICH GCP compliance
• Clinical monitoring
• Trial Master File (TMF) management
• CRF design and implementation
• Data Quality Planning
• Clinical project tracking tools